U.S. Food and Drug Administration • Center for Drug Evaluation and ResearchSkip navigation
CDER - Center for Drug Evaluation and Research Logo

Drug Information

CDER Home Site Information Comments and Feedback What's New CDER Navigation Bar

Tentative Approvals - December 2002

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 75-710 ALENDRONATE SODIUM TABLETS 5 MG (BASE), 10 MG (BASE), 35 MG (BASE), 40 MG (BASE), AND 70 MG (BASE) TEVA PHARMACEUTICALS USA 12/27/02
2 65-105 TOBRAMYCIN SOLUTION FOR INHALATION 300 MG/5 ML VIAL ROXANE LABORATORIES, INC. 12/31/02
3 75-816 CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG/ML PACKAGED IN SINGLE-DOSE AMPULES FAULDING PHARMACEUTICAL COMPANY 12/31/02

totop.gif (1525 bytes) Back to Top   Back Back to Approvals

FDA/Center for Drug Evaluation and Research
Last Updated: January 2, 2003
Originator: OTCOM/DLIS
HTML by SJW